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US regulator says Johnson & Johnson vaccine is 'effective' against Covid-19 and new variants

The vaccine is seen as a vital tool in the pandemic.

Image: PA

THE US BODY responsible for approving vaccines has said the jab developed by Johnson & Johnson is highly effective in preventing severe Covid-19, including the South African and Brazilian variants.

Documents released by the Food and Drug Administration (FDA) show that vaccine efficacy against severe disease in large clinical trials was 85.9% in the United States, 81.7% in South Africa, and 87.6% in Brazil.

An independent FDA panel will meet to discuss the benefits of the vaccine on Friday, with emergency use authorisation possibility following soon after.

It would be the third such vaccine approved to fight Covid-19 in the United States, the world’s hardest-hit country where more than 500,000 people have lost their lives.

Johnson and Johnson’s European subsidiary Janssen has already applied to the European Medicines Agency for EU approval, with a decision possible by next month.

Experts see the J&J vaccine as a vital tool, even though its efficacy against moderate Covid-19 is lower than those Pfizer and Moderna.

“The vaccine was effective in preventing Covid-19 using a less restrictive definition of the disease and for more severe disease, including Covid-19 requiring medical intervention, considering all cases starting 14 days after vaccination,” the new FDA summary said.

“Although a lower efficacy overall was observed in South Africa, where there was a predominance of B.1.3.5 lineage during the time period of this study, vaccine efficacy against severe/critical Covid-19 was similarly high across the United States, South Africa, and Brazil,” it added.

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The vaccine uses a common-cold causing adenovirus, which has been modified so that it can’t replicate, to carry the gene for a key protein of the coronavirus into human cells.

This makes those cells produce that protein, which in turn trains the human immune system.

The fact that it requires only one dose and can be stored at fridge temperature rather than in freezers like the Pfizer and Moderna shots, gives it an operational advantage.

© AFP 2021

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